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Inflamma Dry

by Rapid Pathogen Screening, Inc.

510(k) K132066

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132066 Date21 Nov 2013ClearedStatusActive

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1636-2024 FDA Class II initiated 5 Mar 2024
    • Ongoing Z-1637-2024 FDA Class II initiated 5 Mar 2024

    There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.

    • Terminated Z-2803-2017 FDA Class II initiated 22 Jun 2017

    In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PFQ
Device Class
Class I
Regulation
21 CFR Part 862.1540
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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